The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis (CONCLUDE)

InDex Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: Cobitolimod 500 mg; Drug: Cobitolimod 250 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04985968

CSUC-01/21

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical remission at week 52, in participants with clinical response at week 6 after induction treatment with cobitolimod.

Full description

This phase III study protocol includes an induction study for 6 weeks and a maintenance study for an additional 45 weeks.

In the induction study there will be an initial phase to explore the best dose, between cobitolimod 250 mg and cobitolimod 500 mg using adaptive design.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Induction:

• Male or female ≥ 18 years of age.
• Established diagnosis of UC.
• Moderate to severe active left-sided UC assessed by central reading.
• Have inadequate response, loss of response or be intolerant of at least one of the following treatments: Oral GCS, AZA/6-MP, Biologics, JAK-inhibitors, or other approved advanced therapies for UC.
• Allowed to receive a therapeutic dose of the following UC drugs during the study: Oral GCS therapy (≤20 mg prednisone or equivalent/day) , Oral 5-ASA/SP compounds, AZA/6-MP.
• Ability to understand the treatment, willingness to comply with all study requirements, and ability to provide informed consent.

Exclusion Criteria Induction:

• Suspicion of differential diagnosis.
• Acute fulminant UC and/or signs of systemic toxicity.
• UC limited to the rectum or extending beyond the splenic flexure.
• Have failed treatment with more than three advanced therapies of two different therapeutic classes.
• Have had surgery for treatment of UC.
• History of malignancy, unless treated with no relapse of the disease and ≥ 5 years since last treatment (cured).
• History or presence of any clinically significant disorder.
• Concomitant treatment with cyclosporine, methotrexate, tacrolimus, or advanced therapies or similar immunosuppressants and immunomodulators.
• Treatment with rectal GCS, 5-ASA/SP or tacrolimus.
• Long-term treatment (>14 days) with antibiotics or NSAIDs .
• Serious known active infection including history of latent or active tuberculosis.
• Gastrointestinal infections including positive Clostridium difficile stool assay.
• Females who are lactating or have a positive serum pregnancy test.
• Women of childbearing potential not using highly effective contraceptive methods.
• Concurrent participation in another clinical study.
• Previous exposure to cobitolimod.

Inclusion Criteria Maintenance:

• Participants are eligible to be included in the maintenance study if they have achieved clinical response at week 6 and have adhered to the protocol procedures of the induction study.

Exclusion Criteria Maintenance:

• Participants will not be eligible for the maintenance study if they are not willing to comply with all further study requirements.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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171 participants in 3 patient groups, including a placebo group

Cobitolimod 250 mg

Experimental group

Description:

Dose of 250 mg cobitolimod 2 treatments during induction study and subsequently every third week

Treatment:

Drug: Cobitolimod 250 mg

Cobitolimod 500 mg

Experimental group

Description:

Dose of 500 mg cobitolimod 2 treatments during induction study and subsequently every third week

Treatment:

Drug: Cobitolimod 500 mg

Placebo

Placebo Comparator group

Description:

Dose of Placebo 2 treatments during induction study and subsequently every third week

Treatment:

Drug: Placebo